Nutritional Support for Patients Operated for Malignant Tumors in HPD Zone

Postoperative Clinical Trial

Official title:

Nutritional Support for Patients Operated on for Malignant Tumors of the Hepatico-pancreato-duodenal (HPD) Zone in the Early Postoperative Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06397430
• Other study ID #: MUK_NutS-HPD-PO_2017
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2024
• Source: Karaganda Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A comprehensive comparative analysis of the effectiveness of isolated enteral, isolated parenteral and mixed type of nutritional support in the early postoperative period in patients after operations performed on the malignant neoplasms of hepatico-pancreatico-duodenal zone.

Description:

A prospective, longitudinal, parallel study and retrospective analysis of the results of treatment of 91 patients with malignant tumors of the hepatico-pancreato-duodenal zone who underwent the following operations:

1. resection of various segments of the liver;

2. hemihepatectomy;

3. transhepatic drainage of the right and left hepatic duct;

4. bypass gastroenteroanastomosis or cholecystenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;

5. gastro-pancreato-duodenal resection;

6. corpore-caudal resection of the pancreas with splenectomy.

The first group (n=31) included patients who received enteral nutrition (EN) after surgery. The second group (n=30) included patients who received parenteral nutrition (PN) and the third group (n=30) who received mixed nutrition (MN), as a variation of the partial parenteral nutrition technique, in the early postoperative period.

Some nutritional status indicators available for determination at the Oncology Clinic were assessed - body mass index (weight measurements were carried out before surgery, on the 5th, 10th and 15th days), basal metabolic rate (calculated using the Harris-Benedict equation, based on anthropometric data of the patient (gender, age, weight and height).), laboratory parameters: blood hemoglobin, lymphocytes, total protein, serum albumin, serum transferrin, total bilirubin and direct, alanine aminotransferase (ALT), aspartate aminotransferase (AST), which are related to the traditional method for assessing nutritional status

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

female and male patients in age of 20-75 with malignant tumors of the hepato-pancreato-duodenal zone who have undergone any of the following operations:

1. resection of various segments of the liver;

2. hemihepatectomy;

3. transhepatic drainage of the right and left hepatic duct;

4. bypass gastroenteroanastomosis or cholecystoenteroanastomosis with interintestinal enteroenteroanastomosis according to Brown;

5. gastro-pancreatoduodenal resection;

6. corporecaudal resection of the pancreas with splenectomy.

Exclusion Criteria:

• patients in age of up to 20 and older than 75

• pregnant and breastfeeding women

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Hepato-Biliary Neoplasm
• Nutritional Support
• Postoperative

Intervention

Dietary Supplement:
• parenteral nutrition supplements
parenteral nutrition
• enteral nutrition supplements
enteral nutrition
• mixed nutrition supplements
mixed nutrition

Locations

Country	Name	City	State
Kazakhstan	Karaganda Medical University	Karaganda

Sponsors (1)

Lead Sponsor	Collaborator
Karaganda Medical University

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with changes of BMI in kg/m^2	Variables of Body mass index measured by Canadian Guidelines for Body Weight Classification in Adults	Day 0, Day 5, Day 10, Day15
Primary	Basal Metabolic rate	basal metabolic rate according to the Harris-Benedict equation	Day 0, Day 5, Day 10, Day15
Primary	Total protein level in Blood	Blood biochemical analysis: total protein in g/L	Day 0, Day 5, Day 10, Day15
Primary	Serum albumin in g/L	Blood biochemical analysis: serum albumin in g/L	Day 0, Day 5, Day 10, Day15
Primary	Serum transferrin in g/L	Blood biochemical analysis: serum transferrin in g/L	Day 0, Day 5, Day 10, Day15
Primary	Total bilirubin in mmol/L	Blood biochemical analysis: total bilirubin in mmol/L	Day 0, Day 5, Day 10, Day15
Primary	Direct bilirubin in mmol/L	Blood biochemical analysis: direct bilirubin in mmol/L	Day 0, Day 5, Day 10, Day15
Primary	ALT in IU/L	Blood biochemical analysis: ALT in IU/L	Day 0, Day 5, Day 10, Day15
Primary	AST in IU/L	Blood biochemical analysis: AST in IU/L	Day 0, Day 5, Day 10, Day15